Fitness to Aid the Brain and Cognitive Skills

NCT ID: NCT05367076

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2025-03-11

Brief Summary

The study will assess the feasibility of a pilot clinical trial of community-led aerobic exercise training for paediatric brain tumour survivors (PBTS) and the feasibility of a web-based platform to deliver this exercise training. It is hypothesized that 12 weeks of community-led exercise training will be feasible for PBTS and the web-based platform will be feasible to deliver exercise training by community-based instructors.

Detailed Description

PBTS will complete 12 consecutive weeks of exercise training. Exercise training will involve 90-minute group sessions of aerobic activity 3 times/week with a 30-minute snack/reward time. The investigators anticipate participants will complete the exercise training program in cohorts, each comprised of a minimum of 3 and maximum of 10 participants. With a minimum of 3 participants per cohort, in order for us to achieve the investigators' goal of recruiting 30 participants, the investigators anticipate running approximately 7 cohorts. Participants will be assigned to a cohort based on proximity to session location and availability to attend sessions.

Site Description:

This is a single-site trial, as participants will be recruited from SickKids. Community-led exercise training will be delivered at various locations across the Greater Toronto and Hamilton Area (GTHA). Exercise training sessions will be conducted in partnership with Wellspring, a network of community support services across the GTHA for individuals diagnosed and treated for cancer. The investigators have developed a web-based platform for Fitness Trainers/Therapists (FTTs) to i) educate them on working with PBTS, ii) build exercise session plans, and iii) provide feedback on sessions and overall web-based platform functionality and usability. The web-based platform will allow the administration of community-led exercise training in any location. To test the feasibility of the web-based platform, the investigators will be administering exercise training in approximately 5 locations associated with Wellspring centres (and/or surrounding gymnasiums or outdoor space) and Wellspring FTTs.

Study Intervention Description:

Exercise training will consist of group sessions of aerobic exercise. Each session will include five (5) components:

1. Warm-up activities

2. Aerobic training activities

3. Group sports/games

4. Cool-down activities

5. Snack/reward time The goal of the intervention is to increase and maintain participants' heart rate for at least 30 minutes per session at a minimum of 80% of participants' peak heart rate achieved during a baseline fitness assessment. Increased heart rate will mainly take place during the aerobic circuit training and group sport/game components of each session. Heart rate will be measured using heart rate monitors.

Description of study population:

• Sample size: n = 40 (30 PBTS, 10 Healthy Controls)
• Age: 6-17 years
• Sex: males and females
• General health [PBTS]: Patients who have completed treatment for hemispheric or posterior fossa tumours and do not have severe neurological/motor dysfunction that would preclude safe participation in an exercise program
• General health [Healthy Controls]: Do not have neurological/motor dysfunction that would preclude safe participation in baseline assessment or have a prior history of neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability at time of enrollment
• Geographic location: Canada

Conditions

Pediatric Brain Tumor; Cognitive Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FitABCS exercise

Web-based community-led, 12-week exercise program

Group Type: EXPERIMENTAL

Web-based Aerobic Exercise Program

Intervention Type: BEHAVIORAL

Community based FTTs will use a web-based platform to deliver a 12-week exercise training program (120-minute group sessions of aerobic activity 3 times/week). Each session will include:

• Warm-up activities
• Aerobic activities and fitness training in a game-like fashion
• Organized sports/games
• Cool down activity
• Snack/reward time

FitABCS control

Healthy control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Web-based Aerobic Exercise Program

Community based FTTs will use a web-based platform to deliver a 12-week exercise training program (120-minute group sessions of aerobic activity 3 times/week). Each session will include:

• Warm-up activities
• Aerobic activities and fitness training in a game-like fashion
• Organized sports/games
• Cool down activity
• Snack/reward time

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Between 6 years and 17 years and 11 months of age at time of enrollment

2. Diagnosed with a brain tumour

3. 1 to 15 years between diagnosis and time of study enrollment

4. Medically stable (i.e. must be in remission) as determined by a permanent SickKids staff Neuro-Oncologist

5. Either declare English as their native language or have at least two years of schooling in English at the time of their first assessment

6. Have a parent or legal guardian willing to complete the Health and Quality of Life measures

7. Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardians

Exclusion Criteria

1. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

2. Diagnosed with a neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability prior to initial brain tumour diagnosis that would preclude safe participation

3. Receiving palliative care

4. Require sedation for neuroimaging

5. Have ferrous metal implants (i.e. cochlear implant, braces, etc.)

6. Have a programmable shunt

7. Pregnant

8. Completed any prior cognitive rehabilitation intervention within three months of enrollment

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Donald Mabbott

Senior Scientist and Program Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald J Mabbott

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000073462

Identifier Type: -

Identifier Source: org_study_id